NCT05444231

Brief Summary

This study will investigate the benefits of distinct brain health trainings in breast cancer survivors (age 30-80) with cognitive concerns post-chemotherapy. This study can be completed from the comfort of participant's own home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

June 29, 2022

Last Update Submit

June 5, 2025

Conditions

Breast Cancer Female

Keywords

Cognitive Intervention

Outcome Measures

Primary Outcomes (1)

  • BrainHealth Index Score

    The investigators will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index across multiple timepoints. (Min value = 16, Max value = 1032) (Higher score = Better outcome)

    Baseline, 3 month, 6 month

Secondary Outcomes (4)

  • Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)

    Baseline, 3 month, 6 month

  • Double Decision

    Baseline, 3 month, 6 month

  • Rapid Visual Information Processing

    Baseline, 3 month, 6 month

  • Delayed matching to sample

    Baseline, 3 month, 6 month

Study Arms (3)

Brain Training A

EXPERIMENTAL

This group will access one type of online brain-health oriented training.

Behavioral: Brain Training A

Brain Training B

ACTIVE COMPARATOR

This group will access a distinct type of online brain-health oriented training.

Behavioral: Brain Training B

Brain Training C

ACTIVE COMPARATOR

This group will access a distinct type of online brain-health oriented training.

Behavioral: Brain Training C

Interventions

Brain Training ABEHAVIORAL

Interventions may include education, exercises, and/or strategies to support brain health

Brain Training A
Brain Training BBEHAVIORAL

Interventions may include education, exercises, and/or strategies to support brain health

Brain Training B
Brain Training CBEHAVIORAL

Interventions may include education, exercises, and/or strategies to support brain health

Brain Training C

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female breast cancer survivors who...
  • are between ages of 30-80
  • were diagnosed with Stage I-III
  • received chemotherapy
  • completed chemotherapy at least 6 months ago but not more than 5 years
  • endorse changes in thinking since end of chemotherapy treatment
  • have working internet and a device
  • consider themselves fluent in English

You may not qualify if:

  • Males
  • A re-occurrence of breast cancer or a diagnosis of another
  • An uncorrected hearing or vision issue that would hinder ability to read and/or listen to training material
  • Participation in a cognitive training program in the last 12 months.
  • A reported substance abuse problem
  • Diagnosis of a neurodegenerative disease or psychotic disorder
  • History of stroke, concussion, or brain injury since completing chemotherapy
  • Inability to function independently due to Autism Spectrum Disorder diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for BrainHealth at the University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (11)

  • Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.

    PMID: 23985135BACKGROUND

  • Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021.

    PMID: 33796498BACKGROUND

  • Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014.

    PMID: 24808834BACKGROUND

  • Chapman SB, Aslan S, Spence JS, Keebler MW, DeFina LF, Didehbani N, Perez AM, Lu H, D'Esposito M. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults. Front Hum Neurosci. 2016 Jul 18;10:338. doi: 10.3389/fnhum.2016.00338. eCollection 2016.

    PMID: 27462210BACKGROUND

  • Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing Innovation and Underlying Neural Mechanisms Via Cognitive Training in Healthy Older Adults. Front Aging Neurosci. 2017 Oct 9;9:314. doi: 10.3389/fnagi.2017.00314. eCollection 2017.

    PMID: 29062276BACKGROUND

  • Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12.

    PMID: 29121545BACKGROUND

  • Han K, Davis RA, Chapman SB, Krawczyk DC. Strategy-based reasoning training modulates cortical thickness and resting-state functional connectivity in adults with chronic traumatic brain injury. Brain Behav. 2017 Apr 10;7(5):e00687. doi: 10.1002/brb3.687. eCollection 2017 May.

    PMID: 28523229BACKGROUND

  • Vas A, Chapman S, Aslan S, Spence J, Keebler M, Rodriguez-Larrain G, Rodgers B, Jantz T, Martinez D, Rakic J, Krawczyk D. Reasoning training in veteran and civilian traumatic brain injury with persistent mild impairment. Neuropsychol Rehabil. 2016 Aug;26(4):502-31. doi: 10.1080/09602011.2015.1044013. Epub 2015 May 27.

    PMID: 26018041BACKGROUND

  • Das N, Spence JS, Aslan S, Vanneste S, Mudar R, Rackley A, Quiceno M, Chapman SB. Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Front Neurosci. 2019 Apr 12;13:307. doi: 10.3389/fnins.2019.00307. eCollection 2019.

    PMID: 31031581BACKGROUND

  • Han K, Martinez D, Chapman SB, Krawczyk DC. Neural correlates of reduced depressive symptoms following cognitive training for chronic traumatic brain injury. Hum Brain Mapp. 2018 Jul;39(7):2955-2971. doi: 10.1002/hbm.24052. Epub 2018 Mar 23.

    PMID: 29573026BACKGROUND

  • Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.

    PMID: 27847486BACKGROUND

Study Officials

  • Sandra B Chapman, PhD

    Center for BrainHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 5, 2022

Study Start

August 23, 2023

Primary Completion

March 9, 2025

Study Completion

March 9, 2025

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)